Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:12 AM
Ignite Modification Date: 2025-12-25 @ 11:23 PM
NCT ID: NCT03112993
Description: All-cause mortality, serious adverse events, and other adverse events were systematically assessed by study physician investigators through regular investigator assessment, and through review of subjects' electronic medical records during study participation.
Frequency Threshold: 0
Time Frame: Each subjects was assessed for all-cause mortality, serious adverse events, and other adverse events across their entire duration of study participation, which was the time a subject provided written informed consent until their inpatient hospital discharge following surgery. This time frame was on average 4 days.
Study: NCT03112993
Study Brief: Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sugammadex Group 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Sugammadex: once at the end of the surgery 0 None 2 19 0 19 View
Neostigmine Group 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery 0 None 4 21 0 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ICU admission SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Blood transfusion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Prolonged hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):